Regional Block of the Nose for Hypotensive Anaesthesia in Septo-rhinoplasty

Not Applicable

• Conditions: Hypotensive Anesthesia
• Interventions: Other: General anesthesia with fentanyl boluses; Procedure: Regional block

• Registration Number: NCT03774693
• Lead Sponsor: Ain Shams University

Brief Summary

Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome.

The goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-28
• Status Verified: 2018-12
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17
• Primary Completion: 2019-02
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status I-II
• Scheduled for elective septo-rhinoplasty surgery

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Exclusion Criteria

• Patients with hypertension or coronary artery disease,
• Patients with renal, hepatic or cerebral insufficiency,
• Patients with coagulopathy or receiving drugs influencing blood coagulation,
• Patients with known sensitivity to any of the study drug

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GS [General anesthesia]	General anesthesia with fentanyl boluses	Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.
GR [General anesthesia + regional block]	General anesthesia with fentanyl boluses	Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.
GR [General anesthesia + regional block]	Regional block	Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.

Primary Outcome Measures

Name	Time	Method
Hypotensive anesthesia	Intraoperative	Measurement of Mean arterial blood pressure
Requirements of Fentanyl	Intraoperative	Assessment of intraoperative fentanyl doses of \[Fentanyl boluses of 0.5 mcg.Kg-1 will be given to maintain mean arterial pressure (MAP) between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1\]

Secondary Outcome Measures

Name	Time	Method
Average category scale (ACS)	Intraoperative	The surgeon will be asked, at the end of surgery, to assess bleeding in the surgical field using the average category scale 0-5 scale where \[0=No bleeding and5=Severe bleeding\]

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt